AVAMAX VERTEBRAL BALLOON

K103064 · Care Fusion · NDN · Jan 10, 2011 · Orthopedic

Device Facts

• Record ID: K103064
• Device Name: AVAMAX VERTEBRAL BALLOON
• Applicant: Care Fusion
• Product Code: NDN · Orthopedic
• Decision Date: Jan 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Device Story

AVAmax Vertebral Balloon (Inflatable Bone Tamp) is a balloon catheter system used in kyphoplasty procedures. The device consists of a balloon catheter and a wire stiffener. The physician inserts the catheter into the vertebral body through an access cannula; the balloon is then inflated with a contrast medium to create a cavity in the cancellous bone, reduce the fracture, and prepare the site for bone cement injection. The wire stiffener provides necessary rigidity for insertion. The device is used in a clinical setting by a physician. By creating a controlled void and reducing the fracture, the device facilitates the subsequent delivery of CareFusion Radiopaque Bone Cement, which stabilizes the vertebral body and provides pain relief for the patient.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence is supported by non-clinical bench testing, including inflation pressure (constrained burst test), inflation volume (unconstrained burst test), and balloon wall thickness measurements.

Technological Characteristics

The device is an inflatable bone tamp featuring a polyurethane balloon catheter and a stainless steel wire mandrel. It is designed for use with 11G cannulas. The system is intended for inflation with 60% contrast medium up to a maximum pressure of 400 psi (27 ATM). The balloon is cylindrical in shape with maximum inflation volumes of 4 mL (15mm) or 6 mL (20mm).

Indications for Use

Indicated for patients requiring kyphoplasty for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• CareFusion Inflatable Bone Tamp (K093463)
• Kyphx Inflatable Bone Tamp (K041454)
• Kyphx Inflatable Bone Tamp (K981251)
• Radiopaque Bone Cement (K043518)

Submission Summary (Full Text)

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K103064
JAN 10 2011

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| SUBMITTER INFORMATION | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | CareFusion |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 1625685 |
| Name of contact person | Joy Greidanus |
| Date prepared | 10/28/2010 |
| NAME OF DEVICE | |
| Trade or proprietary<br>name | AVAmax Vertebral Balloon |
| Common or usual name | Inflatable Bone Tamp |
| Classification name | Primary: Arthroscope<br>Secondary: Cement, Bone Vertebroplasty |
| Classification panel | Orthopedic |
| Regulation | Class II per 21CFR §888.1100, Procode HRX:<br>Class II per 21CFR §888.3027, Procode NDN: |
| Product Code(s) | VBT1115, VBT1120 |
| Legally marketed<br>device(s) to which<br>equivalence is<br>claimed | CareFusion Inflatable Bone Tamp, K093463<br>Kyphx Inflatable Bone Tamp, K041454, K981251<br>Radiopaque Bone Cement, K043518 |
| Reason for 510(k)<br>submission | New Device |
| Device description | The Inflatable Bone Tamp (IBT) was designed for use in Balloon kyphoplasty.<br>The balloon serves to create a cavity in the vertebral body, thereby reducing<br>the fracture and preventing cement leakage, while still allowing for cement<br>interdigitation. The balloon catheter is the functional part of the device that<br>creates a cavity and reduces the fracture. The balloon catheter provides a<br>conduit through which the physician can inflate the balloon at the distal end of<br>the catheter. The wire stiffener provides stiffness to the balloon catheter to<br>facilitate insertion through the access cannula |
| Intended use of the<br>device | Intended for the reduction and fixation of fractures and/or creation of a void in<br>cancellous bone in the spine for kyphoplasty (for use with CareFusion<br>Radiopaque Bone Cement) |

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## CareFusion

## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| Characteristic | New Device | Predicate |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Compatible cannula size | 11G | 10G |
| Balloon inflation medium | 60% contrast recommended | 60% contrast recommended |
| Balloon and catheter materials | Polyurethane | Polyurethane |
| Wire mandrel material | Stainless steel | Stainless steel |
| Balloon shape | Cylindrical | Kyphon: Variable<br>CareFusion: Cylindrical |
| Maximum<br>recommended inflation<br>pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum<br>recommended inflation<br>volume (15mm) | 4 mL | Kyphon: 5 mL<br>CareFusion: 4 mL |
| Maximum<br>recommended inflation<br>volume (20mm) | 6 mL | Kyphon: No 20mm size<br>Carefusion: 6 mL |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Inflation pressure | Constrained burst test | The 15mm and 20mm balloon catheters<br>exceeded the requirements for the minimum<br>burst pressure in a constrained environment |
| Inflation volume | Unconstrained burst test | The 15mm and 20mm balloon catheters<br>exceeded the requirements for the minimum<br>burst volume in an unconstrained environment |
| Balloon double wall<br>thickness | Calibrated measurement | The double wall thickness of the 15mm and<br>20mm balloons was substantially equivalent to<br>that of the predicate devices |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | |
| N/A - No clinical tests were conducted for this submission | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA<br>The results of the non-clinical tests show that the CareFusion 11G balloon catheters meet or exceed all | | |

performance requirements, and are substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

CareFusion % Ms. Joy Greidanus Manager, Regulatory Affairs 1 500 Waukegan Road McGaw Park, Illinois 60085

JAN 1 0 201

Re: K103064

Trade Name: Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: December 13, 2010 Received: December 14, 2010

Dear Ms. Greidanus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Or ug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisiops of the Act . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Joy Greidanus

forth in the quality systems (QS) regulation (21 CFR Pari 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11188017/php/fact/ the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (216FR Previ 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

For
Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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K103064
JAN 10 2011

CareFusion 1500 Waukegan Road AcGaw Park, Illinois 60085-6787

## Indication for Use

510(k) Number (if known):

unknown at this time

Inflatable Bone Tamp

Device Name:

Indications For Use:

Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Prescription Use X

Over-The Counter Use or

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division S Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103064

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